MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C US IMPLANT LARGE 6MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.046S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient who was implanted on (b)(6) 2021 with prodisc c at c5/6 has suffered subsidence of the prodisc c implant.There were no reported patient symptoms or complication.No patient comorbidities were indicated.No device malfunction was indicated.There is limited information available from this case.No imaging was provided.On (b)(6) 2022, the patient underwent revision to remove the prodisc c device and replace it with an m6 artificial cervical disc.The surgeon did not provide a clear indication as to what led to the subsidence of the implant.
Additional Manufacturer Narrative
Limited information was provided for this complaint.The information that was provided indicates a patient underwent removal of a prodisc c device due to implant subsidence.There were no reported patient symptoms.There was no reported comorbidities that may have contributed to the subsidence.There was no indication of a device malfunction or explanation as to why the subsidence may have occurred.Based on previous complaints, this event was determined to be surgical intervention to preclude a possible serious injury.Dhr review did not find any manufacturing issues which may have contributed to the event.Complaint history determined the complaint rates equate to a poc of improbable for patient harm.The risk assessment determined the involved risks are identified and mitigated.The device was retrieved, but analysis has not yet begun.If information is provided that changes the conclusion of this submission, a follow up mdr will be completed.The limited information and investigation could not determine a cause for this event.The cause of this event is unknown.This submission is for 1 of 1 devices involved in the event.

• Brand Name: PRODISC C US IMPLANT LARGE 6MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: jason smith ; 900 airport rd, suite 3b; west chester, PA 19380 ; 4848878810
• MDR Report Key: 13656230
• Report Number: 3007494564-2022-00005
• Device Sequence Number: 5974068
• Product Code: MJO
• UDI-Device Identifier: 00843193112828
• UDI-Public: 00843193112828
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 09.820.046S
• Device Catalogue Number: N/A
• Device Lot Number: H695463
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Unknown